Primary Device ID | 09010522002261 |
NIH Device Record Key | 909fe6c4-3f02-4fca-826b-c83fe199d614 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Osstell SmartPeg Type 108 |
Version Model Number | Osstell SmartPeg Type 108 |
Catalog Number | 100781 |
Company DUNS | 633171269 |
Company Name | Osstell AB |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 09010522002261 [Package] Contains: 09010522002278 Package: Box [5 Units] In Commercial Distribution |
GS1 | 09010522002278 [Primary] |
EKX | Handpiece, Direct Drive, Ac-Powered |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-11-09 |
Device Publish Date | 2023-11-01 |
09010522002476 - SmartPeg Type 117 | 2024-05-23 ISQ Measurement Peg |
09010522002070 - SmartPeg Type 98 - Neoss | 2024-05-22 ISQ Measurement Peg |
09010522002469 - Neoss SmartPeg Mount | 2023-12-14 SmartPeg Mount |
09010522002087 - Osstell SmartPeg Type 99 | 2023-11-09 |
09010522002117 - Osstell SmartPeg Type 100 | 2023-11-09 ISQ Measurement Peg |
09010522002131 - Osstell SmartPeg Type 101 | 2023-11-09 ISQ Measurement Peg |
09010522002155 - Osstell SmartPeg Type 102 | 2023-11-09 ISQ Measurement Peg |
09010522002162 - Osstell SmartPeg Type 103 | 2023-11-09 ISQ Measurement Peg |